Public funding of clinical-stage antibiotic development in the United States and European Union

Health Secur. 2015 May-Jun;13(3):156-65. doi: 10.1089/hs.2014.0081.

Abstract

The health and national security challenge of antibiotic resistance has led governments to adopt policies to stimulate new antibiotic R&D. Government programs that directly fund late-stage clinical development of antibiotics have emerged, including the Broad Spectrum Antimicrobial Program of the Biomedical Advanced Research and Development Authority in the United States, and the New Drugs for Bad Bugs program of the Innovative Medicines Initiative in the European Union. These efforts are collectively investing nearly $1 billion and are supporting nearly 20% of the global antibiotic pipeline. This article describes these programs, including the antibiotics and their targeted pathogens and clinical indications, as well as program mechanisms for project eligibility, selection, governance, funding, and IP management. Preliminary assessment of the impact of these mechanisms on the success of the programs is provided.

MeSH terms

  • Anti-Bacterial Agents*
  • Biomedical Research / economics*
  • Drug Discovery / economics*
  • European Union
  • Financing, Government* / methods
  • Government Programs* / organization & administration
  • Health Policy
  • Humans
  • Intellectual Property
  • Technology Transfer
  • United States
  • United States Dept. of Health and Human Services / economics

Substances

  • Anti-Bacterial Agents